Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium...
FDA Recall #Z-0881-2021 — Class II — December 22, 2020
Product Description
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
Reason for Recall
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
Recalling Firm
Abbott Point Of Care Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,521,800 cartridges US and 2,641,053 cartridges OUS
Distribution
Nationwide
Code Information
Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated